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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Solicited symptoms were collected for 3730 and 3740 subjects instead of the 3727 and 3739 subjects who were randomized in the study in the Cervarix and the Havrix groups, respectively. These 4 sujects received both vaccines and were included in the denominator of both arm based on the actual vaccine type administered.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values

Cervarix Group

Havrix Group

Participants Analyzed [Units: Participants]

2635

2677

Number of Cervical Infection With HPV16 or HPV18. [Units: Events]

HPV16 Cervical Infection (N=2464;2452)

50

251

HPV18 Cervical Infection (N=2567;2593)

32

177

HPV16 and/or 18 Cervical Infection (N=2635;2677)

78

387

No statistical analysis provided for Number of Cervical Infection With HPV16 or HPV18.

3. Secondary:

Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type [ Time Frame: From Month 6 up to Month 48 ]

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values

Cervarix Group

Havrix Group

Participants Analyzed [Units: Participants]

380

376

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. [Units: Subjects]

Any pain

214

189

Grade 3 pain

2

0

Any myalgia

250

211

Grade 3 myalgia

1

0

Any arthralgia

44

32

Grade 3 arthralgia

0

0

Any gastrointestinal

157

119

Grade 3 gastrointestinal

0

1

Any headache

247

242

Grade 3 headache

1

2

Any rash

31

26

Grade 3 rash

0

0

Any urticaria

3

1

Grade 3 urticaria

0

0

Fever (oral) >= 37.5°C

43

37

Fever (oral) > 39.0°C

0

0

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.

13. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The following analysis "occurence of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA.